Applicability of PDOX in Patients With Primary Liver Cancer: A Randomized Controlled Trial

Sponsor

Zhujiang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05766605

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Randomized Controlled Trial was to clarity the clinical feasibility of PDOX results in guiding the drug use of interventional chemotherapy after primary liver cancer surgery.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Resectable	Drug: Oxaliplatin Drug: Doxorubicin Drug: Lobaplatin Drug: Cisplatin Drug: Oxaliplatin, Leucovorin, fluorouracil Drug: Lobaplatin, Raltitrexed	Phase 3

Detailed Description

Data of Patients who received PDOX after primary liver cancer radical reaction and received Transarterial Chemoembolization #will be collected

#excluding incomplete data. The primary endpoint was the one-year disease-free survival(DFS) rate #Secondary endpoint was the adverse event.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on PDOX results, and the control group received postoperative conventional treatment combined with empirical transarterial chemoembolization with Doxorubicin.The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on PDOX results, and the control group received postoperative conventional treatment combined with empirical transarterial chemoembolization with Doxorubicin.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Applicability of Patient Derived Orthotopic Xenograft (PDOX) in Patients With Primary Liver Cancer: A Randomized Controlled Trial

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Jan 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the test group The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 months after surgery.	Drug: Oxaliplatin 130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month. Drug: Doxorubicin 20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month. Drug: Lobaplatin 50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month. Drug: Cisplatin 50 mg per square body surface area was used for monthly transhepatic arterial infusions. Drug: Oxaliplatin, Leucovorin, fluorouracil Oxaliplatin(130 mg per square body surface area), Leucovorin(400 mg per square body surface area), and fluorouracil(2800 mg per square body surface area) were used for monthly transhepatic arterial. infusions Drug: Lobaplatin, Raltitrexed Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.
Active Comparator: the control group The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization with Doxorubicin. Empirical transarterial chemoembolization at 1-month intervals for 2 months after surgery.	Drug: Doxorubicin 20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.

Arm

Intervention/Treatment

Experimental: the test group

The test group received postoperative conventional treatment combined with precise transarterial chemoembolization based on PDOX results. Precise transarterial chemoembolization at 1-month intervals for 2 months after surgery.

Drug: Oxaliplatin

130 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.

Drug: Doxorubicin

20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.

Drug: Lobaplatin

50 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.

Drug: Cisplatin

50 mg per square body surface area was used for monthly transhepatic arterial infusions.

Drug: Oxaliplatin, Leucovorin, fluorouracil

Oxaliplatin(130 mg per square body surface area), Leucovorin(400 mg per square body surface area), and fluorouracil(2800 mg per square body surface area) were used for monthly transhepatic arterial. infusions

Drug: Lobaplatin, Raltitrexed

Lobaplatin(50 mg per square body surface area) and Raltitrexed(3 mg per square body surface area) were used for monthly transhepatic arterial infusions.

Active Comparator: the control group

The control group received postoperative conventional treatment combined with Empirical transarterial chemoembolization with Doxorubicin. Empirical transarterial chemoembolization at 1-month intervals for 2 months after surgery.

Drug: Doxorubicin

20 mg per square body surface area for a total of four transcatheter hepatic artery infusions per month.

Outcome Measures

Primary Outcome Measures

The one-year DFS rate [From the start date of the Treatment until date of the time of 1 year]
The one-year DFS rate is defined as the percentage of participants who have not accrued disease at the time of 1 year.

Secondary Outcome Measures

Adverse events [From the beginning of therapy until the date of death from any cause(max 24 months)]
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Undergone radical surgical resection.
Aged 18-75.
Patients voluntarily cooperated with the study and signed an informed consent form.
Histopathologically diagnosed hepatocellular carcinoma.
Patients with R0 resection confirmed by imaging and pathology (no residual lesions and complete tumor resection after radical surgery).
Child-Pugh score of 5-7 (A or B), patients with a score of 7 must be free of ascites.
ECOG physical fitness status score of 0-1.
No serious heart, lung, or renal dysfunction

Exclusion Criteria:

Unable to provide specimens for PDOX testing.
Patients with recurrent liver cancer.
Developing two or more types of tumors simultaneously.
Patients with existing extrahepatic distant metastases.
Treatment with other experimental drugs or other interventions after radical resection.
Patients with other malignant tumors that have not been cured within 5 years.
Patients with non-radical resections (R1 and R2 resections).
Patients with residual or recurrent lesions detected on imaging within 1-2 months after surgery.
Died within 1 month after surgery.